Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
cisatracurium besilate, Quantity: 7.04 mg
Juno Pharmaceuticals Pty Ltd
cisatracurium besilate
Injection, solution
Excipient Ingredients: benzenesulfonic acid; water for injections
Intravenous
5 Pack
(S4) Prescription Only Medicine
Cisatracurium injection is indicated for use during surgical and other procedures and in intensive care to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. It is used as an adjunct to general anaesthesia, or sedation in the intensive care unit.
Visual Identification: A colourless to pale yellow or greenish solution.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2016-01-29
CISATRACURIUM JUNO SOLUTION FOR INJECTION _CISATRACURIUM BESILATE_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cisatracurium Juno Injection. It does not contain all of the available information. Reading this leaflet does not take the place of talking to your doctor or pharmacist. Taking any medicine involves some risk. It is possible that all risks associated with this medicine might not have been detected, despite proper testing. Only your doctor or pharmacist is able to weigh up all of the relevant facts, and you should consult them if you have any queries. IF YOU HAVE ANY CONCERNS ABOUT THE USE OF CISATRACURIUM JUNO INJECTION ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS INFORMATION. You may want to read it again. This leaflet provides information about Cisatracurium Juno Injection. The statements that are made in this leaflet cannot be applied to any other medicine, even those that are similar or appear to contain the same ingredients. WHAT CISATRACURIUM JUNO INJECTION IS USED FOR Cisatracurium Juno Injection is used to relax the body’s muscles. Cisatracurium Juno Injection will normally be given to you when you are in surgery, or during other medical procedures. Cisatracurium Juno Injection is only used in conjunction with an anaesthetic, so you will be asleep during the procedure. IF YOU HAVE ANY QUESTIONS ABOUT WHY CISATRACURIUM JUNO INJECTION IS USED ASK YOUR DOCTOR. _HOW DOES CISATRACURIUM JUNO INJECTION _ _WORK?_ Cisatracurium besilate (the active ingredient in Cisatracurium Juno Injection) belongs to a group of medicines called “neuromuscular blockers”. Cisatracurium Juno Injection works by blocking the effects of one of the body’s chemical messengers called acetylcholine. Acetylcholine is involved in muscle contraction. By relaxing your body’s muscles Cisatracurium Juno Injection makes it easier for you to be kept asleep (under anaesthesia) or sedation. Your doctor will be able to provide you with more information. BEFORE YOU USE CISATRAC read_full_document
Juno Pharmaceuticals Pty Ltd Australian Product Information Page | 1 AUSTRALIAN PRODUCT INFORMATION CISATRACURIUM JUNO (CISATRACURIUM BESILATE) SOLUTION FOR INJECTION _ _ 1 NAME OF THE MEDICINE Cisatracurium besilate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cisatracurium besilate is a white to pale yellow powder. Cisatracurium Juno Injection is supplied in two strengths, either 2 mg or 5 mg of cisatracurium (as besilate) per mL. Cisatracurium Juno Injection does not contain any preservative and is intended for single patient use only. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Cisatracurium Juno Injection is a colourless to pale yellow or greenish solution. It is available in strengths of either 2 mg/mL (ampoules) or 5 mg/mL (vials). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cisatracurium Juno Injection is indicated for use during surgical and other procedures and in intensive care to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. It is used as an adjunct to general anaesthesia, or sedation in the intensive care unit. 4.2 DOSE AND METHOD OF ADMINISTRATION Cisatracurium Juno Injection contains no antimicrobial preservative and is intended for single patient use. USE BY INTRAVENOUS BOLUS INJECTION ADULTS AND ADOLESCENTS OVER 12 YEARS _Tracheal intubation_. The recommended intubation dose of Cisatracurium Juno Injection for adults is 0.15 mg/kg bodyweight. This dose produces good to excellent conditions for tracheal intubation 120 seconds following injection. Higher doses will shorten the time to onset of neuromuscular block. Table 1 summarises mean pharmacodynamic data when cisatracurium besilate was administered at doses of 0.1 to 0.4 mg/kg bodyweight to healthy adult patients during opioid (thiopentone/fentanyl/midazolam) or propofol anaesthesia. Juno Pharmaceuticals Pty Ltd Australian Product Information Page | 2 TABLE 1 Enflurane or isoflurane anaesthesia may extend the clinically effective duration of an ini read_full_document